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Hypertonic Saline Solution in Heart Failure

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ClinicalTrials.gov Identifier: NCT00555685
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : June 10, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
Patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. Some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. The infusion of hypertonic saline solution has been tested in different conditions of cardiovascular collapse. Current evidence indicates that the infusion of hypertonic solution in heart failure patients can provide clinical and haemodynamic improvement. The investigators are testing the hypothesis that the infusion of hypertonic solution in association with diuretics may prevent the occurrence of renal dysfunction in patients with decompensated heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure Renal Failure Hyponatremia Drug: NaCl 7,5% (Hypertonic Saline Solution) Drug: NaCl 0,9% Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Hypertonic Saline Solution in Decompensated Heart Failure
Study Start Date : February 2008
Primary Completion Date : February 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
Group of patients that will receive hypertonic saline solution (NaCl 7,5%)
Drug: NaCl 7,5% (Hypertonic Saline Solution)
Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days
Placebo Comparator: B
Group of patients that will receive placebo
Drug: NaCl 0,9%
Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days

Outcome Measures

Primary Outcome Measures :
  1. Occurrence of renal disfunction [ Time Frame: During hospital admission ]

Secondary Outcome Measures :
  1. Improvement of hyponatremia [ Time Frame: During hospital admission ]
  2. Improvement of congestive phenomena [ Time Frame: During hospital admission ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age over 18 years old
  • Heart failure according to Framingham criteria
  • Episode of acute decompensation,with need of in-hospital treatment
  • Presence of congestive phenomena

Exclusion Criteria:

  • Patient denial
  • Left-ventricle ejection fraction over 0,4, as measure by transthoracic echocardiography
  • Rheumatic disease
  • Restrictive cardiomyopathy
  • Alcohol abuse
  • Chronic obstructive pulmonary disease
  • Cancer
  • Pulmonary embolism during the last 6 months
  • Surgical procedures or acute illness during the last 30 days
  • Chronic or acute infection
  • Any other circumstance that may hamper patient prognosis for the next 6 months
  • Serum creatine over 3.0mg/dL
  • Serum potassium over 5.5 mEqs/L
  • Any specific condition associated to the acute episode of decompensation, such as new onset cardiac arrhythmias, heart ischemia, infection, etc.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555685

Heart Institute of São Paulo University Medical School
Sao Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Edimar A Bocchi, Professor Heart Failure (InCor) University of São Paulo Medical School
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edimar Alcides Bocchi, Heart Failure Team Director, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00555685     History of Changes
Other Study ID Numbers: FAPESP 2007/04048-7
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014

Keywords provided by Edimar Alcides Bocchi, University of Sao Paulo:
Heart Failure
Renal failure

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Pharmaceutical Solutions